Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2003 to 15 August 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2003-08-29
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation, public health

C 204/2

EN

Official Journal of the European Union

29.8.2003

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 July 2003 to 15 August 2003

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93 (1))

(2003/C 204/02)

— Modification of a marketing authorization (Article 12 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

18.7.2003

NovoRapid

18.7.2003

Hycamtin

18.7.2003

NutropinAq

18.7.2003

Orgalutran

22.7.2003

InductOs

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

SmithKline Beecham plc
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

IPSEN Limited
190 Bath Road
Slough
Berkshire SLI 3XE
United Kingdom

Organon NV
PO Box 20
Kloosterstraat 6
5340 BH Oss
Nederland

Wyeth Europa Ltd
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

EU/1/99/119/003,
EU/1/99/119/006

23.7.2003

EU/1/96/027/001,
EU/1/96/027/003-005

23.7.2003

EU/1/00/164/001-002

23.7.2003

EU/1/00/130/001-002

23.7.2003

EU/1/02/226/001

24.7.2003

22.7.2003

Tenecteplase
Boehringer Ingelheim
Pharma GmbH & Co.
KG

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

EU/1/00/168/001-006

24.7.2003

22.7.2003

Replagal

22.7.2003

Ammonaps

22.7.2003

Fabrazyme

23.7.2003

Metalyse

(1) OJ L 214, 24.8.1993, p. 1.

TKT Europe-5S AB
Rinkebyvägen 11B
S-182 36 Danderyd

Orphan Europe
Immeuble «Le Guillaumet»
F-92046 Paris La Défense

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

EU/1/01/189/001-003

24.7.2003

EU/1/99/120/001-004

24.7.2003

EU/1/01/188/001-006

24.7.2003

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

EU/1/00/169/001-006

25.7.2003

29.8.2003

EN

Official Journal of the European Union

C 204/3

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

23.7.2003

Pegasys

23.7.2003

Regranex

28.7.2003

Pritor

28.7.2003

Evista

28.7.2003

Optruma

28.7.2003

Travatan

28.7.2003

IntronA

28.7.2003

Aprovel

28.7.2003

Mabthera

29.7.2003

Viraferon

29.7.2003

Viagra

30.7.2003

Aerius

30.7.2003

Allex

Roche Registration Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

Alcon Laboratories Ltd
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Sanofi Pharma
Bristol-Myers Squibb SNC
174, avenue de France
F-75013 Paris

Roche Registration Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

EU/1/02/221/001-008

25.7.2003

EU/1/99/101/001

25.7.2003

EU/1/98/089/001-016

30.7.2003

EU/1/98/073/001-004

30.7.2003

EU/1/98/074/001-004

30.7.2003

EU/1/01/199/001-002

30.7.2003

EU/1/99/127/001-044

30.7.2003

EU/1/97/046/001-015

30.7.2003

EU/1/98/067/001-002

30.7.2003

EU/1/99/128/001-037

31.7.2003

EU/1/98/077/001-012

31.7.2003

EU/1/00/160/001-034

1.8.2003

EU/1/00/159/001-034

1.8.2003

C 204/4

EN

Official Journal of the European Union

29.8.2003

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

30.7.2003

Azomyr

30.7.2003

Neoclarityn

30.7.2003

Opulis

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

EU/1/00/157/001-034

1.8.2003

EU/1/00/161/001-034

1.8.2003

EU/1/00/158/001-034

1.8.2003

30.7.2003

Avonex

Biogen France SA «Le Capitole»
55, avenue des Champs Pierreux
F-92012 Nanterre Cedex

EU/1/97/033/001-002

1.8.2003

30.7.2003

Karvea

Bristol-Myers Squibb Pharma EEIG
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

EU/1/97/049/001-015

1.8.2003

1.8.2003

NovoNorm

1.8.2003

Prandin

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/98/076/001-002,
EU/1/98/076/004-009,
EU/1/98/076/011-016,
EU/1/98/076/018-021

5.8.2003

EU/1/00/162/001-018

7.8.2003

1.8.2003

Infanrix hexa

GlaxoSmithKline Biologicals SA
Rue de l'Institut 89
B-1330 Rixensart

EU/1/00/152/001-018

5.8.2003

1.8.2003

Viread

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

5.8.2003

5.8.2003

Fabrazyme

5.8.2003

Rapamune

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

Wyeth Europa Limited
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

EU/1/01/188/001-006

8.8.2003

EU/1/01/171/009-010

7.8.2003

5.8.2003

Vaniqa

Women First HealthCare Limited
Westwood High Street
Staplehurst
Kent TN12 0BH
United Kingdom

EU/1/01/173/001-003

12.8.2003

29.8.2003

EN

Official Journal of the European Union

C 204/5

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

7.8.2003

Humalog

7.8.2003

Infanrix hexa

7.8.2003

Rapilysin

11.8.2003

Nespo

11.8.2003

Xigris

11.8.2003

Prevenar

11.8.2003

Aranesp

13.8.2003

Velosulin

13.8.2003

Actraphane

13.8.2003

Actrapid

13.8.2003

Mixtard

13.8.2003

Insulatard

13.8.2003

Protaphane

13.8.2003

Enbrel

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

GlaxoSmithKline Biologicals SA
Rue de l'Institut 89
B-1330 Rixensart

Roche Registration Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

Dompé Biotec SpA
Via San Martino 12
I-20122 Milano

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

EU/1/96/007/001-028

11.8.2003

EU/1/00/152/001-018

11.8.2003

EU/1/96/018/001

11.8.2003

EU/1/01/184/001-032

13.8.2003

EU/1/02/225/001-002

13.8.2003

Wyeth-Lederle Vaccines SA
Rue du Bosquet 15
B-1348 Louvain-La-Neuve

EU/1/00/167/003-004,
EU/1/00/167/006-007

13.8.2003

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Wyeth Europa Limited
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

EU/1/01/185/001-032

13.8.2003

EU/1/02/232/003

15.8.2003

EU/1/02/229/036-037

15.8.2003

EU/1/02/230/016-017

15.8.2003

EU/1/02/231/036-037

15.8.2003

EU/1/02/233/016-017

15.8.2003

EU/1/02/234/016-017

15.8.2003

EU/1/99/126/001-003

15.8.2003

C 204/6

EN

Official Journal of the European Union

29.8.2003

— Issuing of a marketing authorization (Article 34 of Regulation (EEC) No 2309/93): Accepted

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

22.7.2003

Gonazon

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/03/040/001

24.7.2003

— Modification of a marketing authorization (Article 34 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

22.7.2003

Dicural

22.7.2003

Metacam

1.8.2003

Metacam

1.8.2003

Metacam

Fort Dodge Animal Health Holland
C. J. van Houtenlaan 36
1381 CP Weesp
Nederland

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/003/001-018

24.7.2003

EU/2/97/004/003-005

24.7.2003

EU/2/97/004/003-005

5.8.2003

EU/2/97/004/007-008

5.8.2003

Anyone wishing to consult the public assessment report on the medicinal products in question and the
decisions relating thereto is invited to contact:

The European Agency for the Evaluation of Medicinal products
7 Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom.

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 July 2003 to 15 August 2003

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

— Lift of suspension of a marketing authorization

(2003/C 204/03)

Date of
the decision

Name(s) of the
medicinal product

Holder(s) of the marketing
authorization

Member State concerned

Date of
notification

14.7.2003

Felodipine

See Annex

See Annex

15.7.2003

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.